Treats major depressive disorder (MDD). NDA 21336, held by Somerset. Selegiline.
As of Nov 15, 2026, NDA 21336 (Emsam), held by Somerset, was first approved by FDA on Feb 27, 2006, with 7 approved supplements and 0 published complete response letters.
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD). EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD).
| Sep 10, 2014 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Feb 27, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Emsam6MG/24HR · film, extended release;transdermal | Selegiline | RxReference drug |
| Emsam9MG/24HR · film, extended release;transdermal | Selegiline | RxReference drug |
| Emsam12MG/24HR · film, extended release;transdermal | Selegiline | RxReference drug |
| Jul 14, 2017 | Supplement 14Labeling · Standard review | Approved | |
| Oct 16, 2015 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 27, 2015 | Supplement 11Labeling · Standard review | Approved | |
| Sep 10, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Sep 10, 2014 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Feb 13, 2008 | Supplement 1Labeling · Standard review | Approved | |
| Jul 30, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Feb 27, 2006 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
